Validation of a Novel Frailty Index in Surgical Cohorts

• Sponsor: University of Iceland (Other)
• Overall Status: Completed
• CT.gov ID: NCT03971851
• Collaborator: (none)
• Enrollment: 50,000
• Actual Duration (Months): 183

Study Details

Study Description

Brief Summary

This study will validate the utility of a novel frailty index that uses ICD diagnoses to call frailty severity in a surgical cohort of patients 65 and older

Condition or Disease	Intervention/Treatment	Phase
Surgery--Complications; Anesthesia Morbidity; Perioperative Complication	Other: Frailty risk groups

Study Design

• Study Type: Observational
• Actual Enrollment: 50000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Testing and Validation of a Novel Frailty Index in a Surgical Cohort
• Actual Study Start Date: Jan 1, 2005
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Low frailty Frailty risk score less than 5	Other: Frailty risk groups; Patients older than 65 will be separated into groups of varying frailty risk
Intermediate Frailty Frailty risk score 5-15	Other: Frailty risk groups; Patients older than 65 will be separated into groups of varying frailty risk
High frailty Frailty risk score 15 and above	Other: Frailty risk groups; Patients older than 65 will be separated into groups of varying frailty risk

Outcome Measures

Primary Outcome Measures

1. 30-day mortality [30-days]

   Mortality within 30 days of surgery in each of the three frailty risk groups

2. Time to hospital readmission [Up to 180 days]

   For patients surviving index hospitalization, the proportional hazard ratio of readmission between the three frailty group

Secondary Outcome Measures

1. Long-term mortality [Up to 14 years]

   Long-term mortality of the three different frailty risk groups, compared with proportional hazard modeling

2. Prolonged hospital length-of stay [3 months]

   Incidence of patients staying more than 10-days after surgery in the three frailty risk cohorts

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients 65 years or older, undergoing any surgery at Landspitali University Hospital with an anesthesia team involved

Exclusion Criteria:

• No American Society of Anesthesiology classification provided

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Iceland

Investigators

• Principal Investigator: Martin I Sigurdsson, MD, PhD, University of Iceland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Iceland
• ClinicalTrials.gov Identifier: NCT03971851
• Other Study ID Numbers: FrailtyAndSurgery
• First Posted: Jun 3, 2019
• Last Update Posted: Nov 4, 2020
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Frailty

Study Results

No Results Posted as of Nov 4, 2020